DOST officials meet with Russian vaccine manufacturers for Phase 3 trial

Officials of the Department of Science and Technology (DOST) met with the manufacturers of the Russian vaccine for the coronavirus disease 2019 (COVID-19) on Wednesday to discuss the third phase of clinical trials.

DOST Undersecretary Rowena Guevara said representatives from the Gamaleya Research Institute of Russia, the DOST, and the Philippine vaccine expert panel discussed the process of registering the “Sputnik V” vaccine in the Philippines.

Guevara said they also took up the conduct of phase 3 clinical trials in the Philippines, “possibly simultaneous to phase 3 clinical trial in Russia.”

Under the third and final phase of clinical trials, the efficacy and safety of the vaccine will be tested on 300 to 3,000 volunteers, according to the Food and Drug Administration (FDA).

Russia’s vaccine has received criticism for receiving regulatory approval without the crucial phase 3 trial. 

Guevara said the vaccine’s approval in the Philippines will involve “getting confidentiality agreement signed, review of phase 2 and phase 3 clinical trial results, apply for FDA permission to do the trial, and undertake the phase 3 clinical trial.”

“After the trial, Gamaleya can apply for registration with FDA so that the vaccine can be used in the Philippines. The meeting went well,” she added.

Health Secretary Francisco Duque III earlier said more studies and information are still needed on the Russian vaccine. 

Malacañang reiterated its support for a possible cooperation with Russia on vaccine development and production, adding it underscored deepening ties between the two countries.

“As we have said, the Philippines is ready to work with Russia, on clinical trials, vaccine supply and production, among others, subject to our existing laws and local processes,” presidential spokesperson Harry Roque said in a statement.

“Cooperation on public health, especially at a time when it is most needed, can be a cornerstone convergence. It is a good opportunity to enhance ties with our key partners.”

President Rodrigo Duterte previously said he would be the first to be inoculated with the vaccine in the Philippines once it becomes available. —Julia Mari Ornedo/Virgil Lopez/LDF, GMA News